We are an international company developing software for hospitals, laboratories and other medical facilities located in various countries in Europe and the world. For our partner from the USA – SCC, we are looking for candidates for the position of QA/RA Contractor, responsible for research, analysis, creation and documentation of regulatory and quality data pertaining to SCC’s medical devices. The person in this position works closely with SCC’s Quality Management Division and all operational areas to ensure compliance to the regulations and assist in product development at supplier sites.
- Analysis of guidance documents, work instructions, and other publications from FDA, ISO, and other regulatory agencies to determine the impact on SCC and Suppliers’ Quality System.
- Providing assistance to Suppliers in understanding and complying with applicable regulations
- Interpretation and implementation of quality assurance/regulatory standards and providing accurate and comprehensive feedback to management
- Participation in regulatory inspections.
- Assistance with Regulatory Assessments on new and existing products for determining the classification as a medical device in the applicable jurisdictions/countries prior to distribution.
- Assistance with overseeing document control, CAPA, auditing, and any other QA/RA activities as directed by management.
- Monitoring of preventative and corrective actions to ensure that quality assurance standards are achieved.
- intermediate MS Office skills (required)
- knowledge of SharePoint, Adobe Professional, MS Project
- Excellent planning and organizational skills
- Very good oral and written communication skills in English (min.B2)
- Very good interpersonal and communication skills
- knowledge of FDA regulations, ISO standards, Auditing, and Software Development Lifecycle is preferred
- please send your CV in English
We can offer you:
- form of cooperation: B2B contract with SCC Poland
- salary range: 5500 – 6000 net
If you are interested, please e-mail your CV to: email@example.com with the note: QA/RA Contractor – Rzeszow
Please include the following clause in your CV:
“I hereby give consent for my personal data to be processed by SCC Soft Computer Poland Sp. z o.o. [Ltd.] residing in Rzeszow, at Leszka Czarnego 6A for the purpose of recruitment process”
If you want us to consider your application also in the future recruitment processes, please include an additional clause in your CV:
“I hereby also give consent for my personal data to be processed by SCC Soft Computer Poland Sp. z o.o. [Ltd.] residing in Rzeszow, at Leszka Czarnego 6A for the purpose of future recruitment processes”